ZYN becomes first FDA-authorised nicotine pouch in US

The US Food and Drug Administration (FDA) has on Thursday authorised ZYN nicotine pouches making the brand the first and only authorised nicotine pouch in the US.

Brand owner Swedish Match, a subsidiary of Philip Morris International, said the FDA’s authorisation of all ZYN nicotine pouches currently marketed in the US is an important step to protect the public health by providing better alternatives to cigarettes and other traditional tobacco products for adults.

“An estimated 45 million Americans regularly consume nicotine and about 30 million of them smoke, the most harmful form of nicotine consumption,” said Tom Hayes, president of Swedish Match North America, LLC.

“The FDA’s decision recognises the role that ZYN can play in the protection of the public health by helping people switch from cigarettes and other traditional tobacco products.”

The FDA’s evaluation showed that, due to substantially lower amounts of harmful constituents than cigarettes and most smokeless tobacco products, such as moist snuff and snus, the authorised products pose lower risk of cancer and other serious health conditions than such products.

The agency also highlighted the evidence from a study showing that a substantial proportion of adults who use cigarette and/or smokeless tobacco products completely switched to the newly authorized nicotine pouch products.

“To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks,” said Matthew Farrelly, director of the Office of Science in the FDA’s Center for Tobacco Products.

“In this case, the data show that these nicotine pouch products meet that bar by benefiting adults who use cigarettes and/or smokeless tobacco products and completely switch to these products.”

Additionally, the FDA found that these nicotine pouch products have the potential to provide a benefit to adults who smoke cigarettes and/or use other smokeless tobacco products that is sufficient to outweigh the risks of the products, including to youth. As part of its evaluation, the FDA reviewed data regarding youth risk and found that youth use of nicotine pouches remains low despite growing sales in recent years.

“It’s critical that the manufacturer market these products responsibly to prevent youth use,” said Brian King, director of the FDA’s Center for Tobacco Products. “While current data show that youth use remains low, the FDA is closely monitoring the marketplace and is committed to taking action, as appropriate, to best protect public health.”